Retsch-Bogart George Z, Quittner Alexandra L, Gibson Ronald L, Oermann Christopher M, McCoy Karen S, Montgomery A Bruce, Cooper Peter J
University of North Carolina at Chapel Hill, Chapel Hill, NC.
University of Miami, Coral Gables, FL.
Chest. 2009 May;135(5):1223-1232. doi: 10.1378/chest.08-1421.
We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection.
In this randomized, double-blind, placebo-controlled, international study (AIR-CF1 trial; June 2005 to April 2007), patients (n = 164; >or= 6 years of age) with FEV(1) >or= 25% and <or= 75% predicted values, and no recent use of antipseudomonal antibiotics or azithromycin were treated with 75 mg of AZLI (three times daily for 28 days) or placebo (1:1 randomization), then were monitored for 14 days after study drug completion. The primary efficacy end point was change in patient-reported respiratory symptoms (CF-Questionnaire-Revised [CFQ-R] Respiratory Scale). Secondary end points included changes in pulmonary function (FEV(1)), sputum PA density, and nonrespiratory CFQ-R scales. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored.
After 28 days of treatment, AZLI improved the mean CFQ-R respiratory score (9.7 points; p < 0.001), FEV(1) (10.3% predicted; p < 0.001), and sputum PA density (- 1.453 log(10) cfu/g; p < 0.001), compared with placebo. Significant improvements in Eating, Emotional Functioning, Health Perceptions, Physical Functioning, Role Limitation/School Performance, and Vitality CFQ-R scales were observed. Adverse events were consistent with symptoms of CF lung disease and were comparable for AZLI and placebo except the incidence of "productive cough" was reduced by half in AZLI-treated patients. PA aztreonam susceptibility at baseline and end of therapy were similar.
In patients with CF, PA airway infection, moderate-to-severe lung disease, and no recent use of antipseudomonal antibiotics or azithromycin, 28-day treatment with AZLI significantly improved respiratory symptoms and pulmonary function, and was well tolerated.
Clinicaltrials.gov Identifier: NCT00112359.
我们评估了吸入用氨曲南赖氨酸（AZLI，一种雾化单环β-内酰胺类抗生素）对囊性纤维化（CF）合并铜绿假单胞菌（PA）气道感染患者的短期疗效和安全性。
在这项随机、双盲、安慰剂对照的国际研究（AIR-CF1试验；2005年6月至2007年4月）中，对FEV(1)为预测值的25%至75%且近期未使用抗假单胞菌抗生素或阿奇霉素的患者（n = 164；年龄≥6岁），给予75mg的AZLI（每日三次，共28天）或安慰剂（1:1随机分组）治疗，在完成研究药物治疗后监测14天。主要疗效终点是患者报告的呼吸症状变化（CF问卷修订版[CFQ-R]呼吸量表）。次要终点包括肺功能（FEV(1)）、痰液PA密度和CFQ-R非呼吸量表的变化。监测不良事件以及氨曲南对PA的最低抑菌浓度。
治疗28天后，与安慰剂相比，AZLI改善了CFQ-R呼吸平均评分（9.7分；p < 0.001）、FEV(1)（预测值的10.3%；p < 0.001）和痰液PA密度（-1.453 log(10) cfu/g；p < 0.001）。在饮食、情绪功能、健康认知、身体功能、角色限制/学校表现和活力CFQ-R量表方面观察到显著改善。不良事件与CF肺部疾病症状一致，AZLI和安慰剂的不良事件相当，但接受AZLI治疗的患者“咳痰”发生率降低了一半。治疗基线和结束时PA对氨曲南的敏感性相似。
在CF、PA气道感染、中重度肺部疾病且近期未使用抗假单胞菌抗生素或阿奇霉素的患者中，28天的AZLI治疗显著改善了呼吸症状和肺功能，且耐受性良好。
Clinicaltrials.gov标识符：NCT00112359。
